Treatment CLI Nonrevascularizable Lower Limb With Cell Therapy (HULPVAS)
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|ClinicalTrials.gov Identifier: NCT01824069|
Recruitment Status : Completed
First Posted : April 4, 2013
Last Update Posted : June 15, 2016
It has been demonstrated the feasibility, safety and effectiveness of mesenchymal stem cells derived from lipoaspirate for treating various pathologies fistula. With this project we will address a study population with critical ischemia of lower limbs without possibility of revascularization, either by technical criteria (no intervention possible to compensate for the lack of irrigation of a limb) criteria or risk / benefit (intolerable surgical risk for the type of intervention required). It will almost always elderly patients with multiple comorbidities and high surgical risk who have a lower limb ischemia in critical degree, with very high probability of major amputation in the short term or immediate.
Hypothesis: mesenchymal stem cells obtained by lipoaspirate expanded "ex vivo", are capable of promoting angiogenesis de novo to improve critical limb ischemia lower nonrevascularizable a safe manner
|Condition or disease||Intervention/treatment||Phase|
|Nonrevascularizable Critical Ischemia of the Lower Limbs||Other: Intramuscular injection of a suspension of adult mesenchymal stem cells derived||Phase 1 Phase 2|
The primary endpoint of safety and feasibility study will be done when the patient has received treatment at 12 months after implantation. It defines that the process is safe when in the development and monitoring of the trial there has been no adverse events that may be related to the proposed therapy in the trial. All adverse events will be collected during the same time monitoring the clinical evaluation. The main objective will be assessed the cumulative incidence of adverse effects attributed to the study therapy.
Secondary endpoints: As part of the evaluation of the quality of life of patients and clinical evaluation of the treatment will be at 6, 9 and 12 months after implantation a Test SF-12, a magnetic resonance angiography, and tissue oximetry records ankle-brachial index
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase IIa Clinical Trial to Safety of Treatment in Critical Ischemia Nonrevascularizable Lower Limb by Mesenchymal Stem Cells|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||September 2015|
Experimental: Autologous mesenchymal stem cells
Intramuscular injection of a suspension of adult mesenchymal stem cells derived from adipose tissue at doses of 1 million per kilo of weight in a dosis
Other: Intramuscular injection of a suspension of adult mesenchymal stem cells derived
Intramuscular injection of a suspension of adult mesenchymal stem cells derived from adipose tissue at doses of 1 million per kilo of weight. Only one dosis by patients
- Safety of inject mesenchymal stem cells in MMII [ Time Frame: one year ]It defines that the process is safe when in the development and monitoring of the trial there has been no adverse events that may be related to the proposed therapy in the trial.
- Quality of life of patients after treatment [ Time Frame: one year ]We analyze the quality of life of patients by SF-12 test
- Clinical evaluation of patients after treatment [ Time Frame: One year ]Clinical evaluation of patients after treatment with magnetic resonance angiography, tissue oximetry records and ankle-brachial index.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01824069
|Hospital Universitario La Paz|
|Madrid, Spain, 28046|
|Principal Investigator:||Luis Riera del Moral, Doctor||Instituto de Investigación Hospital Universitario La Paz|